- federal always trumps state, unless state is more stringent
attorney general opinions = lawjQuery110104333017041649827_1501801078309?
NO, they are guidances so you couldn't be criminally tried for not following the opinion, but can be civically tried d/t not following "standard of care"
legal actions against pharmacists?
- usually between individuals, where money compensation is involved d/t individual being harmed/injured by pharmacist actions
- when law broken and government entity brings action
- falls on infraction, misdemeanors, or felony classifications (usually misdemeanor)
- involves SBOP taking action against pharmacists license
California State Board of Pharmacy Members?
11 appointed by governor
2 appointed by committee of state Senate and Speaker of Assembly
7 must be RPH with 5 in at least one of the following settings
-acute care hospital
-independent community pharmacy (pharmacist cannot own >4 pharmacies)
-chain community pharmacy (75 or more pharmacies in Cali)
-long-term healthcare or SNF
-member of labor union representing pharmacists
State Board Inspectors and Executive Officer of the Board = Pharmacists? don't need to be registered pharmacists
written drug order requirements for NP, CNM, PA
printed name, address, phone # of supervising prescriber
printed/stamped name and license number of NP, CNM, PA
signature of NP, CNM, PA
pharmacy technicians can call for refill requests? YES. but if Rx expires (aka > 1 year old) - then cannot, needs pharmacist or intern to take over call b/c technically now a new rx
for schedule III-IV meds - then if it exceeds 5 refills, 120 days of refills, or 6 months (whichever comes first) - then technically new rx and pharmacist or intern must take over call
for schedule V meds - if exceeds 6 months or no more refills, then new rx and pharmacist or intern must take over call (CHECK)
DEA FORMS: 224, 225, 363, 222, 106, 41
224 - registration form for retail rx, hospitals/clinics, practitioners, teaching institutions, mid-level practitioners
225 - registration form for manufacturers, distributors, researchers, analytical labs, import/exporters
363 - registration form for narcotic tx programs
222 - ordering schedule I and II drugs
106 - reporting theft or significant loss of CS
41 - record of CS destroyed
DEA 222 Forms Copies
Copy 1 = brown (always goes to whoever sends the drugs)
Copy 2 = green (always goes to the DEA from the person who sends the drugs)
Copy 3 = blue (always goes to whoever gets the drugs)
brown --> green --> blue
(how the water from the mountain flows down to the ocean)
nonscheduled drugs or C-III through V, if lent/borrowed/sold/bought between pharmacies: Who keeps records?
BOTH parties involved
record - item transacted, date, name of drug, strength, amount, who made transaction, and if lent/borrowed/sold/bought
keep records for 3 years
report pending bankruptcy, insolvency, or receivership within?
72 hours to SBOP
How long till report to SBOP: change in licensee's residential address; ownership change of pharmacy; drug robbery of CS; fire destroying 80% of rx inventory
- fires can result in smoke, ashes, or moisture... if drug package exposed, then its adulterated and must be reported to SBOP and DEA (if scheduled)
can employee or pharmacist deliver medication to a pt?
YES, but make sure it only goes to designated parties (DUH)
Prescription Pricing Info
- give current retail price for any drug sold at rx upon walk-in request of consumer
- if request for rx prices of >5 drugs, can charge reasonable fee as long as I tell them that
- not required to give price quotes for >3 requests for 5 or more rx drugs from any one person or entity in 6 month period
- not obligated to provide drug prices if coming from person out of state
- no need provide price for CS rx if request via telephone
- not required to give price to competitor
- you must display somewhere in pharmacy that's readable by consumer:
- that price info is available
physicians can hold how many shares of a COMMUNITY pharmacy corporation?
if hospital or non-profit or HMO's --> can be exclusively owned by physicians
psychiatry (not psychologist)
if blatant violation of the law
not in best interest of the pt
selling drugs to profit pharmacies from non profit pharmacies? PROHIBITED, can only be BORROWED!!
non-profit can be sold to non-profit if sold to a walk-in customer and the sales are <1% of drugs purchased by the seller AND if emergency situation where no other soruces are readily available to meet emergency need
minimum area of community pharmacy?
reasonable area sufficient to accommodate for safe and efficient performance of rx-related activities
if furnishing drug under state of emergency, what do I keep record of?
date, name, address of pt
name, strength, quantity of drug
prescribers name, address, phone number
no need reason, but should be documented
if using central fill pharmacy, then whose labels and whose inventory are used?
the central fill pharmacies, don't use other pharmacy's inventory that originally received the prescription
physicians can only write CS rx's for people OTHER THAN THEMSELVES?
for estrogen products, must provide the product package insert?
CURES: controlled substance utilization and review evaluation system
- schedules II-IV reported weekly
- schedules II-III reported monthly if 48 hour or less rx
- schedule IV not reported if 48 hour or less rx
apomorphine a controlled substance?
NO, not in California
not enough to offer to consult b/c pt can refuse/accept
- must orally consult pt unless hospital discharge med
- therefore cannot just provide written information, needs ORAL CONSULT
if pt not present (aka MAIL ORDER or DELIVERY) --> responsibility shifted to pt to request consult... so pharmacist DOES NOT HAVE TO call pt, but they should receive a written notice of right to request consultation, and telephone number to call for consult
if hospital discharge, person other than pharmacist can provide pt consulting
out of state prescriptions?
if written by out of state prescriber, if non-scheduled drug then treated as if written by Cali prescriber. aka can dispense rx directly to pt
if CS (II-V) issued by out-of-state prescriber, can be filled and DELIVERED/MAILED to pt as long as the rx meets the requirements for CS rx's of the state where it's written
- helps accommodate pts who use out-of-state mail order pharmacies
cannot dispense C-II rx's to pt if written from out-of-state prescriber (only can deliver)
can dispense C-III through V DIRECTLY to pt if written on california security form or if orally authorized
if your pharmacy has no record of the prescription, it's illegal to dispense a rx to the pt
mandatory counseling points
directions for use
directions for STORAGE
importance of compliance
precautions and relevant warnings
side effects or interactions
pharmacy license voided, or pharmacy owner notifies the Board of intent to remain closed, how long till notifying board?
within 10 days
cream to ointment or ointment to cream without contacting MD?
NO, illegal. only can change if it would benefit the pt aka can't swallow so put tablet/capsule into suspension form
can't just change it b/c you're OOS
internet non-scheduled rx's?
must have name/initials of person sending it (prescriber or his/her designee) AND assurances that med was ordered as result of good faith exam by prescriber
for animal prescriptions?
need type of animal, name of owner and address of owner on prescription
mercury thermometers require prescriptions?
non-pharmacists can own pharmacies but not have possession of a key to the pharmacy?
pts have the right to have their info withheld from entry into a common electronic network filing system?
TRUE, but no waiver to sign to prevent this exists
CS III-V refills?
120 day supply (doesn't include first fill)
5 refills max
6 month period (for C-II's too, but don't have refills allowed)
MAKE SURE YOU NOTE THE DAY SUPPLY! not just the total days since rx filled (which is max 6 months)
any disciplinary action in another state = disciplinary action for California?
pharmacies that do specialized compounding can advertise they compound specific drug products?
clinic pharmacies CANNOT dispense C-II rx's?
if terminally ill pt from SNF or inpatient hospice and has C-II rx, partial fill?
YES, must be partial filled within 60 days from the date rx written m
pharmacies can furnish compounded products to prescribers for office use no more than a 72 hour supply?
YES (aka reasonable quantity)
- make sure to label with name/amount of each ingredient, total weight/volume, appropriate expiration date, and "Prescriber's Office Use"
exemption 11159.2 is for what?
terminally ill pts getting C-II rx's on regular rx blanks
optometrists prescribing scope of practice?
must have the TPA designation
- variety of PO abx
- 3 day supply or PO codeine or hydrocodone when mixed with non-scheduled drug
- topical anti-inflammatory (including steroids)
- topical anti-glaucoma
- topical antivirals
- PO acyclovir
NOT IM or IV abx
if board inspector issues citation to pharmacist or pharmacy, how long till appealing?
within 30 days
order of abatement
something within the pharmacy must be corrected within a given time
EC ok for 17 years old and older?
YES...but only for Plan B... (plan B one-step has no age restriction OTC)
- can give the 2 tablets at same time
can charge up to $10 admin fee for services rendered in addition to retail cost of EC drug if dispensed as RX (if OTC, no admin fee can be charged)
if providing EC under protocol (aka pt has no rx from prescriber, but wishes to use insurance) requires one hour of CE on emergency contraception... if OTC, no CE required
if OTC (aka plan B or plan B one-step), no counseling required, if under protocol, counseling required
only one drug ingredient exists under Plan B (2 tabs of levonorgestrel 0.75mg each) - must be 17 years old
dispensing replaceable contact lenses?
-must register with Medical Board of Cali at time of initial app of license
-rx must contain state license # of prescribing practitioner before filling
-expiration date on label must state no more than 1 year from date of last prescribing exam
-no generic substitution
-must provide pt with following notice:
"warning - if you have any unexplained eye discomfort, watering, vision change, or redness, remove lenses immediately and consult with eye doc"
if CS, cannot be designated as PRN refills?
C-II's cannot be refilled
C-III through V must have designated amount of refills on rx
changing brand to generic drugs?
must communicate with pt that its saving money and ask for permission to dispense generic
change of pharmacist address or name, change of PIC, change in pharmacy permit - notify board of pharmacy how soon?
within 30 days
veterinary drugs have on package labeling
caution, federal law restricts this drug to use by or on the order of a licensed veterinarian
multispecialty clinic vs. surgical clinic:
multi can dispense whatever amount called for on rx
surgical can only dispense an amount no more than 72 hour pt need
if you forget to renew your license, how long till you can no longer renew, reinstate, or restore it?
3 years (YES)
but... if license retired... then cannot be reinstated to active license... need to retake licensing exams
- retired doesn't mean inactive... if inactive, then can reinstate before 3 years is up
if rx transferred (even by email), can you omit prescriber's address, license class, and federal registry #?
YES, if readily retrievable in receiving rx
if non-scheduled drug, and pt runs out of refills, and cannot contact prescriber, then can you refill?
YES, if in your judgment it would interfere with ongoing care or adverse effects could occur.
you could just give 3 day supply, but you can also give the same amount as the previous refill
if rx under court-ordered receivership, owner of pharmacy notifies SBOP how soon?
if 5 or more rx prices are requested?
pharmacist can require a written statement of request but must respond within a reasonable time (10 days)
- may charge reasonable fee for each quotation, even though requesting customer doesn't get the rx's filled, as long as they know of this charge
pharmacy not required to respond to more than 3 requests of this type from any person within a six month period
can't add the price quote to the regular charge of getting rx filled
immunizations and physicians and pharmacists
must be physician in charge, but doesn't need to be present
protocol that outlines who gets or doesn't get immunizations, and action if injury occurs
physician doesn't need to provide rx for each individual who qualifies for immunization
- notify PCP in 30 days
- vaccination reported to state/local immunization information system in 30 days (tell pt you did this)
- pt must be 3 years or older
National Vaccine Injury Compensation Program - only protected from adverse reactions
Quality Assurance Program on medication errors?
don't need to report to SBOP
names of personnel involved don't need to be on report
no need do med error report if it was corrected before getting to pt
do investigation within 2 business days
hold onto med error report for at least 1 year
Cali Labor Codes... pharmacist = non-exempt employee... but what's the exception to non-exempt status of pharmacist?
EXCEPTION - can work 8 hours/day and 40 hrs/week at one rx, and work full-time or part-time at another pharmacy independently owned/operated relative to first rx
all herbals containing ephedrine or ephedrine-like products are still available OTC?
NO, removed by FDA
if storing records off-site, what do you need?
waiver from SBOP, NOT license
provide requested records to SBOP from storage site within 2 business days
temporary pharmacy permit can be good for how long?
180 days... if pharmacy sold to new owner
can prescribers direct rx to be labeled with any info that is false/misleading?
labeling necessary part of clinical/investigational study approved by FDA
in medical judgment of prescriber, labeling is appropriate for proper treatment of pt (aka placebo in place of actual drug)
retain record stating the manner in which info on rx label varies from actual drug in container and documenting order of the prescriber to label the container in that manner. RETAIN FOR 3 years
hospital 100 beds or less? what type of pharmacist required?
consultant pharmacist at least (must provide written reports/recommendations of pharmacy services at least quarterly)
you can dispense drugs without full-time pharmacist if:
- inpatients being discharged
- emergency cases under tx by hospital
- dispensing directly by physician to outpatients IF:
- physician determines immediate use is warranted
- physician believes no other rx available/accessible within 30 mins or 30 mile radius of hospital
- no more than 72 hr supply of drug
- properly label and dispense directly by prescriber
can't just dispense drugs for outpt use pursuant to physician's rx... needs requirements
if rx closes or permit revoked, how long to notify board and arrange for transfer or all rx drugs to another rx or wholesaler?
10 days... once transfer completed, notify SBOP immediately in writing
if ordering schedule II drugs from out-of-state person, pharmacy must:
forward true and correct copy of order, contract, or agreement for procurement of such C-II drugs to attorney general's office WITHIN 24 hour of transmitting order
if C-II through C-V rx, when you change something on rx, what do you have to do?
just talk to prescriber, document you talked to them about the error/omission
how long do you keep HIPAA statements for (signed vs. unsigned)
CNM's can furnish rx's for C-II through C-V if they are registered with DEA and in accordance with physician's protocol and its furnished in connection with prenatal, perinatal, maternal or family planning?
pharmacists and DEA #'s for furnishing controls?
if PIC of pharmacy leaves, temporary PIC can be in charge for how long?
you need application for proposed replacement PIC.... if denied, must propose another in 15 days and continue to do so until PIC approved... if unable to identify replacement in 30 days, can propose any pharmacist to act as the interim or temporary PIC for 120 days
ephedrine products restrictions?
3.6 g per day, 3 packages per day, 9 grams per month, 18 years or older, LOGBOOK
no need logbook for 60mg pseudoephedrine purchases
"must refrigerate" or "shake well" a required AUXILIARY LABEL?
NO, a required manufacturer label
drugs that don't require child-proof containers?
isosorbide dinitrate SL or chewable 10mg or less
refrigeration of medications (not freezing) temp?
2.2 to 7.7 degrees celsius
take rx's brought into pharmacy
answer non-prescriber phone calls
put drug back into rx drug stock (after fill)
CANNOT TAKE DRUGS OFF SHELVES to fill rx's
only have to report in 14 days of theft to state board if?
licensed person in pharmacy (pharmacist, intern, tech)
just report in 30 days that drugs were stolen... can fire and notify police of course
what other jurisdictions can we fill rx's for?
guam, virgin islands, puerto rico, american samoa
when rx considered closed?
if not engaged in ordinary activity for at least one day each calendar week during any 120 day period
continuing education course records?
compounding of sterile products in pharmacy licensing?
both community and hospital must have separate license for sterile compounding
renewable yearly subject to annual inspection by SBOP
nonsterile compounding = NO SEPARATE LICENSE REQUIREDf
suboxone can only be used to treat addictions for what schedule?
III-V and NOT for C-II addictions
physician must be certified to prescribe the drug
expiration date max on extemporaneous unit dose blister packs?
to have the word drug, or anything similar, OR characteristic rx or pharmacy sign... the store needs to have?
a pharmacy... with license from SBOP
what can CURES be used for?
ONLY for accessing information for the care of his/her pts
centralized hospital pharmacy in Cali can do compounding/preparation of extemporaneous unit dose packaging for?
any hospital owned by same owners
must be located within 75 miles of each other
must have barcoding to be used for checking accuracy of med admin at pt's bedside
if newly licensed or renewed on or after July 1st, 2018... must complete at least 6 hrs of the required 30 hrs of CE in one of these areas?
maintaining control of rx's drug inventory
substance abuse, (indications of red flags and pharmacists' responsibility)
cannot sell, purchase, or trade or offer to sell, purchase or trade any drug sample
if provided drug sample by licensed prescriber, you could dispense pursuant to order by authorized prescriber to pt at no cost (excess rules doe)
- must have written/signed document that samples are to be provided to pts pursuant to rx
- must be on official government form and have: practitioner's name, address, professional designation, name/strength of sample, number provided, name of manufacturer, and signature of practitioner
what can you tell pt about BP reading?
what it was
if low, normal, high
advise to consult with physician if deemed necessary
font size on pt's label?
12 point sans serif typeface
50% of label contains:
- name of pt
- name/strength of drug
- directions for use
- condition or purpose if indicated on rx
suggested to be in bold or highlighted or color background to help
can pharm techs sign for rx invoices deliveries?
NO... only pharmacist! (or pharmacist intern)
the designated representative term is for wholesalers or veterinary food-animal drug operations (this person doesn't have to be a pharmacist)
lending, borrowing, selling, buying drugs between pharmacies?
nonscheduled and CIII-V require log book to record transactions